Evaluation of Radiology Resident Anxiety When Beginning E... | NCT00859066

Studies
Evaluation of Radiology Resident Anxiety When Beginning Emergency Room (ER) Call

NCT00859066

Sponsor

University of Michigan

Status

Terminated

Last Update Posted

Apr 30, 2012Estimated

Enrollment

19Actual

Phase

Not provided

Conditions

Anxiety
Stress

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Original Principal Investigator (Andrew Trout M.D.) left the University.

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Oct 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Mar 9, 2009

First Submission Date that Met QC Criteria

Mar 9, 2009

First Posted Date

Mar 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2012

Last Update Posted Date

Apr 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to quantify levels of resident anxiety under the current system (take call alone) and compare results to a modified system.

Detailed Description

The study purpose is to quantify resident perceptions and feelings under the current 1700 call system (take call alone) and compare those with resident perceptions and feelings under a modified system where two partial shifts are taken with an experienced resident ("buddy call") prior to taking call alone.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group		First year University of Michigan Radiology residents will take call as scheduled without a "buddy call" experience. (Enrollment completed for the control group)
Experimental Group		2009 class of first year Radiology residents who will be assigned two 5 hour shifts working side by side with a more senior resident (who has experience taking call).

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improve resident well-being by decreasing anxiety surrounding beginning ER call as a first year radiology resident.		12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

first year radiology residents

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

First year radiology residents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard Cohan, M.D.	University of Michigan Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Michigan Hospital		Ann Arbor	Michigan	48109	United States